AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS

Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

ALLEGIANCE HEALTHCARE CORP.

The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Airlife Heated Ventilator And Breathing Circuits.

Pre-market Notification Details

Device IDK993833
510k NumberK993833
Device Name:AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
ClassificationHeater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Applicant ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park,  IL  60085
ContactSharon Robbins
CorrespondentSharon Robbins
ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park,  IL  60085
Product CodeBZE  
CFR Regulation Number868.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-12
Decision Date1999-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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30889483572676 K993833 000
30889483572287 K993833 000
30889483584105 K993833 000

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